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Non-cancer Pain and Cognitive Impairment: A Disabling Relationship

This study is not yet open for participant recruitment.
Verified December 2010 by University of Chicago
Sponsor:
Information provided by:
University of Chicago
ClinicalTrials.gov Identifier:
NCT01264965
First received: December 20, 2010
Last updated: December 21, 2010
Last verified: December 2010
History of Changes
  Purpose

To compare the efficacy of long-acting oxycodone to extended-release acetaminophen in older persons with no and mild to moderate cognitive impairment and persistent moderate or higher intensity non-cancer lower extremity arthritis pain; and Describe the association of change in non-cancer pain self-report with an older adults functional status (BPI and WOMAC and brief physical performance measure) and to determine if cognitive status modifies this relationship.


Condition Intervention
Arthritis
Pain
Cognitive Impairment
 Drug: long acting oxycodone
Drug: extra strength acetaminophen

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Opioids Versus Extra Strength Acetaminophen for the Management of Moderate Persistent Non-cancer Pain

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • pain self-report on the brief pain inventory and WOMAC [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • discontinuation of study drug, short physical performance battery [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 155
Study Start Date: January 2011
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Acetaminophen Drug: extra strength acetaminophen
1,000 mg twice daily
Active Comparator: Long Acting Oxycodone Drug: long acting oxycodone
10mg twice daily

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. age over 65
  2. Pain at least 3 months duration
  3. Pain greater in lower extremity than other anatomical site with ambulation
  4. Pain self-report of moderate intensity of higher on an average day
  5. Community-dwelling
  6. Ambulatory
  7. Physician states participants have decision-making capacity to enroll into the trial
  8. Participants with cognitive impairment have a reliable caregiver
  9. Inadequate pain relief from NSAIDS and/or acetaminophen in the past

Exclusion Criteria:

  1. Current cancer requiring chemotherapy
  2. History of addiction to opioids or other controlled substance
  3. Consumes more than 2 alcoholic drinks a day
  4. Severe balance disturbance
  5. Intra-articular steroid injection in the past 6 weeks
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01264965

Contacts
Contact: Joseph W Shega, MD 773-834-7999 jshega@medicine.bsd.uchicago.edu
Contact: William Dale, MD, PhD 773-834-0508 wdale@medicine.bsd.uchicago.edu

Locations
United States, Illinois
University of Chicago Medical Center Outpatient Senior Health Center South Shore
Chicago, Illinois, United States, 60649
Sponsors and Collaborators
University of Chicago
  More Information

No publications provided

Responsible Party: Joseph W. Shega, MD, University of Chicago
ClinicalTrials.gov Identifier: NCT01264965     History of Changes
Other Study ID Numbers: K23AG029815-03
Study First Received: December 20, 2010
Last Updated: December 21, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
Pain
Analgesia
Cognitive impairment
Randomized controlled trial
Physical function

Additional relevant MeSH terms:
Arthritis
Cognition Disorders
Joint Diseases
Musculoskeletal Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Acetaminophen
Oxycodone
Antipyretics
Physiological Effects of Drugs
 Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Narcotics
Central Nervous System Depressants
Analgesics, Opioid

ClinicalTrials.gov processed this record on October 18, 2012